ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.

Study Overview

• Status: Completed
• Conditions: Childhood Acute Lymphoblastic Leukemia in Remission
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment; Dietary supplement: nutritional intervention; Behavioral: exercise intervention; Other: follow-up care; Behavioral: counseling intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphoblastic leukemia (ALL) patients or those at high risk to become so (body mass index [BMI] >= 50th percentile).

II. Assess changes in BMI z-score, waist circumference, body composition, blood pressure exercise tolerance and physical activity at baseline, immediately post intervention and three months later.

III. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention.

IV. Assess changes in self-reported quality of life, physical activity, caloric intake, and fatigue associated with the nutrition and exercise program in the participant and their primary caregiver.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.

ARM II: Patients receive standard of care individualized diet and exercise plan.

After completion of study treatment, patients are followed up at 3 and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion
• English speaking patient and primary caregiver
• BMI >= 75th percentile at time of study enrollment; (patients >= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy)
• Provision of informed consent by primary caregiver

Exclusion Criteria:

• Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)
• As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (intervention); Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Dietary supplement: nutritional intervention; Receive nutritional intervention; Behavioral: exercise intervention; Receive exercise intervention; Other: follow-up care; Receive booster follow-up sessions from the nutritionist and exercise physiologist; Behavioral: counseling intervention; Receive phone counseling with a trained health coach; Other Names: counseling and communications studies
No Intervention: Arm II (control); Patients receive standard of care individualized diet and exercise plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program.	Patients undergo a nutrition and counseling intervention designed to decrease their calorie intake, meet micronutrient recommendations, and participate in an exercise plan. Feasibility is defined as >50% of patients who complete the intervention	Baseline and at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of increase or decrease in BMI of pediatric ALL patients with a BMI > 75th percentile who undergo a nutrition and counseling intervention compared to a control group of pediatric ALL patients who do not undergo intervention	At 3 months and at 6 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Adam Esbenshade, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Adiponectin, Glucose, Insulin, Leptin
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: VICC PED 1309; P30 CA 68485 OD (Other Grant/Funding Number: National Cancer Institute); 2K12CA090625-11- A) (Other Identifier: RAC); 2K12CA090625-11 (U.S. NIH Grant/Contract)